The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic

Ida-Lina Diak (), Kimberley Swank, Kate McCartan, Maya Beganovic, James Kidd, Neha Gada, Rachna Kapoor, Lisa Wolf, Laura Kangas, Jo Wyeth, Toni Salvatore, Melina Fanari, Andrew A. LeBoeuf, Poonam Mishra, Michael D. Blum and Gerald Dal Pan
Additional contact information
Ida-Lina Diak: US Food and Drug Administration
Kimberley Swank: US Food and Drug Administration
Kate McCartan: US Food and Drug Administration
Maya Beganovic: US Food and Drug Administration
James Kidd: US Food and Drug Administration
Neha Gada: US Food and Drug Administration
Rachna Kapoor: US Food and Drug Administration
Lisa Wolf: US Food and Drug Administration
Laura Kangas: US Food and Drug Administration
Jo Wyeth: US Food and Drug Administration
Toni Salvatore: US Food and Drug Administration
Melina Fanari: US Food and Drug Administration
Andrew A. LeBoeuf: US Food and Drug Administration
Poonam Mishra: US Food and Drug Administration
Michael D. Blum: US Food and Drug Administration
Gerald Dal Pan: US Food and Drug Administration

Drug Safety, 2023, vol. 46, issue 2, No 4, 145-155

Abstract: Abstract Introduction On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to coronavirus disease 2019 (COVID-19), and on 27 March, 2020 declared circumstances existed to justify the authorization of the emergency use of drug and biological products (hereafter, “drugs”) for COVID-19. At the outset of the pandemic with uncertainty relating to the virus, many drugs were being used to treat or prevent COVID-19, resulting in the US Food and Drug Administration’s (FDA’s) need to initiate heightened surveillance across these drugs. Objective We aimed to describe the FDA’s approach to monitoring the safety of drugs to treat or prevent COVID-19 across multiple data sources and the subsequent actions taken by the FDA to protect public health. Methods The FDA conducted surveillance of adverse event and medication error data using the FDA Adverse Event Reporting System, biomedical literature, FDA-American College of Medical Toxicology COVID-19 Toxicology Investigators Consortium Pharmacovigilance Project Sub-registry, and the American Association of Poison Control Centers National Poison Data System. Results From 4 February, 2020, through 31 January, 2022, we identified 22,944 unique adverse event cases worldwide and 1052 unique medication error cases domestically with drugs to treat or prevent COVID-19. These were from the FDA Adverse Event Reporting System (22,219), biomedical literature (1107), FDA-American College of Medical Toxicology COVID-19 Toxicology Investigator’s Consortium Sub-registry (638), and the National Poison Data System (32), resulting in the detection of several important safety issues. Conclusions Safety surveillance using near real-time data was critical during the COVID-19 pandemic because the FDA monitored an unprecedented number of drugs to treat or prevent COVID-19. Additionally, the pandemic prompted the FDA to accelerate innovation, forging new collaborations and leveraging data sources to conduct safety surveillance to respond to the pandemic.

Date: 2023
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DOI: 10.1007/s40264-022-01256-2

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